Institute for Medical Device Compliance & Regulations
Can my medical device be produced by a non-ISO 13485 certified manufacturer?
To have or not to have? To certify or not?
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Want to apply risk-based thinking? This you should know
ISO 13485:2016 requires companies to use risk-based thinking to manage
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Risk Management according to ISO 14971
In a fast-paced world, the risks companies are exposed to
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What risk-based approach to QMS means?
The new version of the ISO 13485:2016 standard expects companies
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